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Start PreambleStart Printed Page 65835

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

SUMMARY:

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Virbac AH, Inc. The supplemental NADA provides revised labeling for ivermectin and praziquantel oral paste used in horses for the treatment and control of various internal parasites.

SUPPLEMENTARY INFORMATION:

Virbac AH, Inc., 3200 Meacham Blvd., Ft. Worth, TX 76137, filed a supplement to NADA 141-215 for EQUIMAX (ivermectin 1.87%/praziquantel 14.03%) Paste for horses. This supplement amends product labeling to separate parasite life stages in the indications section. The supplemental NADA is approved as of September 16, 2005, and the regulations in 21 CFR 520.1198 are amended to reflect the approval. The basis of approval is discussed in the freedom of information summary. The current regulations for ivermectin and praziquantel paste are also being revised to remove redundant language. These changes are being made to improve the readability of the regulations.

In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.

The agency has determined under 21 CFR 25.33(d)(1) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 520 is amended as follows:

End Amendment PartStart Part

PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS

End PartStart Amendment Part

1. The authority citation for 21 CFR part 520 continues to read as follows: